Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

September 13, 2018

Primary Completion Date

March 12, 2020

Study Completion Date

March 12, 2020

Conditions
Overt Hepatic Encephalopathy
Interventions
DRUG

40 mg Rifaximin SSD once daily

SSD once daily (QD)

DRUG

40 mg Rifaximin SSD twice daily

SSD twice daily (BID)

DRUG

80 mg Rifaximin SSD once daily

SSD once daily (QD)

DRUG

80 mg Rifaximin SSD twice daily

SSD twice daily (BID)

DRUG

Placebo

Administered twice daily (BID)

Trial Locations (34)

10029

Bausch Health Site 09, New York

10065

Bausch Health Site 28, New York

11215

Bausch Health Site 36, Brooklyn

15213

Bausch Health Site 12, Pittsburgh

19104

Bausch Health Site 11, Philadelphia

19107

Bausch Health Site 26, Philadelphia

19141

Bausch Health Site 10, Philadelphia

23226

Bausch Health Site 30, Richmond

23249

Bausch Health Site 06, Richmond

29425

Bausch Health Site 16, Charleston

33136

Bausch Health Site 08, Miami

38801

Bausch Health Site 25, Tupelo

43210

Bausch Health Site 23, Columbus

45219

Bausch Health Site 17, Cincinnati

48109

Bausch Health Site 07, Detroit

48127

Bausch Health 01, Detroit

52242

Bausch Health Site 33, Iowa City

53226

Bausch Health Site 20, Milwaukee

60611

Bausch Health Site 05, Chicago

63104

Bausch Health Site 24, St Louis

75203

Bausch Health Site 22, Dallas

75246

Bausch Health Site 35, Dallas

75390

Bausch Health Site 31, Dallas

77001

Bausch Health Site 02, Houston

77030

Bausch Health Site 37, Houston

90033

Bausch Health Site 15, Los Angeles

90048

Bausch Health Site 19, Los Angeles

92118

Bausch Health Site 18, Corona del Mar

94143

Bausch Health Site 04, San Francisco

98104

Bausch Health Site 21, Seattle

98195

Bausch Health Site 14, Seattle

06010

Bausch Health Site 13, Bristol

02215

Bausch Health Site 03, Boston

07102

Bausch Health Site 27, Newark

All Listed Sponsors
lead

Bausch Health Americas, Inc.

INDUSTRY

NCT03515044 - Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE) | Biotech Hunter | Biotech Hunter